GAIN Report – JA6029 Page 2 of 9
Voluntary Report - public distribution
Date: 6/20/2006
GAIN Report Number: JA6029
JA9999
Japan
Sanitary/Phytosanitary/Food Safety
Proposed Changes to Standards on Metconazole; Cyazofamid; Enrofloxacin; and Regulations on e. coli levels in certain wheat products.
2006
Approved by:
Rachel Nelson
U.S. Embassy
Prepared by:
Rachel Nelson
Report Highlights:
On June 15 the Japanese Ministry of Health, Labour and Welfare (MHLW) informed Tokyo based Embassies of its intention to Establish new MRLs for the pesticides Metconazole and
Cyazofamid, to establish MRLs for the veterinary drug Enrofloxacin, and to partially revise the Official Specifications and Standards for e. coli in certain wheat based products. These changes are currently open for public comments until June 29, 2006. Sometime after comments are received, a final draft will be submitted to the WTO for an additional public comment period.
Includes PSD Changes: No
Includes Trade Matrix: No
Unscheduled Report
Tokyo [JA1]
[JA]
(I)Establishment of Maximum Residue Limits for Metconazole and Cyazofamid,
Pesticides, in Food
Purpose
This activity is to develop specifications and standards for foods. Under the provisions of Article 11, Paragraph 1 of the Food Sanitation Law, the Minister of Health, Labour, and Welfare may establish maximum residue limits (MRLs) for agricultural chemicals that may remain in foods. Any food for which standards are established pursuant to the provisions, is not permitted to be marketed unless such food complies with the established standards.
On November 29, 2005 the Ministry of Health, Labour and Welfare issued
notifications regarding the positive list system for agricultural chemicals in food
(Notification Nos. 497, 498, and 499). Under the system, which became effective on May 29, 2006, basically, any agricultural chemical in food in the Japanese marketplace is subject to residue standards based on the law.
Outline of the activity
Metconazle (Fungicide): This chemical is currently not permitted for use in Japan. This proposal is to newly approve it under the Agricultural Chemicals Regulation Law.
In step with approval, the MHLW will establish new MRLs. See the list of draft
MRLs (Attachment 1).
Cyazofamid (Fungicide): This chemical is already approved. The scope of target crops on which it is permitted for use will be expanded. In step with the expansion of scope, the MHLW will additionally establish MRLs for some crops. In addition, some of the provisional MRLs, which have been set in Notification No. 499, will be revised based on scientific data. See the list of draft MRLs (Attachment 2).
Revised provisional MRLs will be removed from the provisional MRLs list in the Specifications and Standards for Food, Food Additives, Etc (Part I Food, Section A General Compositional Standards for Food, Item 7) and placed in the MRLs list (Item 6 of Section A).
Attachment 1. draft changes
Metconazole (Fungicide)
Commodity draft MRL (ppm)
Wheat 0.2
UNSHU orange 0.1
NATSUDAIDAI (whole) 0.2
Lemon 0.3
Orange (including Navel) 0.3
Grapefruit 0.3
Lime 0.3
Other citrus fruits 0.3
UNSHU orange (peel) 3
Attachment 2.
Cyazofamid (Fungicide)
Commodity Current MRL Draft MRL (ppm)
Wheat 0.05 0.05
Beans (dry) 0.1
Potato 0.05 0.05
Taro 0.02
Japanese radish (root) 0.05
Japanese radish (leaf) 10
Turnip (including Rutabaga)(root) 0.3
Turnip (including Rutabaga)(leaf) 20
Chinese cabbage 1 0.7
Cabbage 0.05 0.05
Kale 15
KOMATSUNA 15 15
KYONA 10
Qing-geng-cai 3
Broccoli 1
Other cruciferous vegetables 15
Onion 0.05 0.05
Welsh (including Leek) 2
Other liliaceous vegetables 3
Tomato 2 2
Pimento (Sweet pepper) 1 1
Eggplant 0.5 2
Other solanaceous vegetables 1 1
Cucumber (including Gherkin) 0.7 0.7
Pumpkin (including Squash) 0.1 2
Oriental pickling melon (vegetable) 0.1 2
Water melon 0.05 0.05
Melons 0.05 0.05
MAKUWAURI 0.1 0.1
Other cucurbitaceous vegetables 0.1 0.1
Spinach 25 25
Ginger 0.7
UNSHU orange 0.7
NATSUDAIDAI (whole) 2
Lemon 5
Orange (including Navel) 5
Grapefruit 5
Lime 5
Other citrus fruits 5
Strawberry 0.7
Grape 10 10
Other fruits 1 10
UNSHU orange (peel) 10
Other spices (except UNSHU peel) 1 10
Other herbs 15
(II) Discussion on the Establishment of Standards for Enrofloxacin, Veterinary Drug, in Food
(Summary)
I Background
This activity is to establish standards for enrofloxacin, an antibiotic. Enrofloxacin is the major effective ingredient of certain veterinary medicines (Baytril raw materials, Baytril 10% solution, Baytril 2.5% HV solution, and Baytril 2.5%, 5%, and 10% injectable solutions) which are approved under the Pharmaceutical Affairs Law. For this substance, residue standards for food (provisional MRLs) are already established. This time, an application has been made to MAFF for reassessment of these drugs based on the legal requirement, under which reassessment must be conducted every six years after veterinary drugs are once approved. In step with reassessment, the MHLW is going to review the provisional MRLs as the Food Safety Commission in the Cabinet Office has set the acceptable daily intake (ADI) of this substance.*
Note: Under the 2003 amendment of the Food Sanitation Law, when an application is made to MAFF for the approval of an agricultural chemical, the MHLW is required to establish MRLs for the chemical. Provisional MRLs are MRLs which have been provisionally established for the implementation of the positive list system for agricultural chemical residues in food, which became effective on May 29, 2006.
II Summary report of discussion at the Joint Committee on Agricultural Chemicals and
Veterinary Drug under the Pharmaceutical Affairs and Food Sanitation Council
1. Substance
Enrofloxacin
Chemical name: 1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3
-quinoline carboxylic acid
2. Use (treatment of bacterial infections of the respiratory and alimentary tract)
It is categorized as a fluoroquinolone and effective against gram-negative bacteria as well as
various gram-positive bacteria. In Japan, it is used to treat bacterial respiratory infections
(Mycoplasma bovis, Ureaplasma divesum, Pasteurella multocida) and coliform-bacterial diarrhea of cattle and pigs, and respiratory mycoplasma infections (Mycoplasma gallisepticum) and coliform-bacterial infections of chickens. Ciprofloxacin, a metabolite of enrofloxacin, has anti-bacterial activity and widely used in human medicine.
3. Acceptable daily intake (ADI)
According to risk assessment by the Food Safety Commission, NOAEL (No Observed Adverse
Effect Level) for two-year chronic toxicity study in rats was 2.9 mg/kg body weight. The ADI was derived as 0.029 mg/kg body weight/day, applying a safety factor of 100, which consists of two 10-fold factors for interspecies differences and for interindividual variability in humans. On the other hand, the ADI derived from microbiological effects based on in vitro MIC50 values was 0.002 mg/kg body weight/day, applying a faecal bolus of 220 g, 20% for the quantity of the ingested amount which would be available to the bacteria at the distal part of the intestine, and a body weight of 60 kg.
ADI (mg/kg bw/day = 0.000125(mg/ mL) X220 g= 0.002mg / kg bw / day
0.2 X 60(kg)
* The value is based on findings in humans of the metabolite, ciprofloxacin.
In the comparison of the two ADIs, the microbiological ADI is lower than the toxicological ADI.
The commission has adopted the stricter one and established an ADI of 0.002 mg/kg body weight for enrofloxacin.
The assessment report from the commission is available (Japanese only) at
http://www.fsc.go.jp/hyouka/hy/hy-hyouka-enrofloxacin.pdf
4. Regulatory status in other countries
Enrofloxacin is permitted for use in food producing animals, such as cattle and pigs, in many
countries. MRLs are established in each country. See the table given below. On September 12, 2005 the United States withdrew the approval of the use of this substance in chickens, based on risk assessment of enrofloxacin-resistant campylobacter. In the EU, MRLs are set for all food producing animals, but the use in cultured aquatic animals is not approved. The JECFA (Joint FAO/WHO Expert Committee on Food Additives) has assessed the safety of the substance and established an ADI of 0.002 mg/kg body weight/day.
MRLs by countries (Unit: ppm)
Target tissue USA EU (3) Canada Japan (5)
Cattle
Muscle 0.1 0.02 0.01
Fat 0.1 0.01
Liver 0.1 0.3 0.07 0.01
Kidney 0.2 0.01
Other edible parts (1) 0.01
Milk 0.1 0.02
Porcine
Muscle 0.1 0.01
Fat 0.1 0.01
Liver 0.2 0.01
Kidney 0.3 0.01
Other edible parts 0.01
Other terrestrial mammals
Muscle 0.1 0.1
Fat 0.1 0.1
Liver 0.3 0.3
Kidney 0.2 0.2
Other edible parts 0.2
Chicken
Muscle 0.1 0.01
Fat 0.1 0.01
Liver 0.2 0.01
Kidney 0.3 0.01
Other edible parts 0.01
Other fowls
Muscle 0.1 0.1
Fat 0.1 0.1
Liver 0.2 0.2
Kidney 0.3 0.3
Other edible parts 0.2
Fin fish and shellfish (2) 0.1 (4) 0.1
Note
1. “Other edible parts” refer to all edible parts except the muscle, fat, liver, and kidney.
2. “Fin fish and shellfish” refer to all edible fin fish and shellfish
3. The limits of the EU are expressed as the sum of residue levels of enrofloxacin and ciprofloxacin.
4. A MRL of 0.1 applies the MRL for the muscle for all food producing species except cattle, sheep, pigs, goats, rabbits, and poultry.
5. The Japanese MRLs are provisional MRLs specified in the Minister of Health, Labour and Welfare Notification No. 499, published in November 29, 2005 and implemented on May 29, 2006.
5. Draft maximum residue limits (MRLs)
a. Target substances to regulate
Enrofloxacin and Ciprofloxacin
b. The table shows draft MRLs. The MRLs were established taking residue studies into
consideration. Japan will not establish MRLs for fin fish and shellfish since most foreign countries do not approve the use of enrofloxacin in such animals and there occur no residue studies for cultured aquatic animals. The MHLW will review the MRLs given below when the commission has completed assessment of effects of bacterial resistance to enrofloxacin and ciprofloxacin.
Tissue (animal species) MRL (ppm) 2 Tissue (animal species) MRL (ppm) 2
Cattle Chicken
Muscle 0.05 Muscle 0.05
Fat 0.05 Fat 0.05
Liver 0.1 Liver 0.1
Kidney 0.1 Kidney 0.1
Other edible parts1 0.05 Other edible parts 1 0.1
Milk 0.05
Porcine Other fowls
Muscle 0.05 Muscle 0.05
Fat 0.05 Fat 0.05
Liver 0.1 Liver 0.1
Kidney 0.1 Kidney 0.1
Other edible parts1 0.05 Other edible parts1 0.1
Other terrestrial mammals
Muscle 0.05
Fat 0.05
Liver 0.1
Kidney 0.1
Other edible parts1 0.05
Note
1. For other edible parts, MRLs were based on residue study results of the small intestine for cattle and pigs, and on residue study results of the liver and kidney for chickens.
2. MRLs are expressed as the sum of residue levels of enrofloxacin and ciprofloxacin.
c. Ratio of ADI
The table shows the ratios of the TMDI (theoretical maximum daily intake) to the ADI. The
TMDI refers to the amount of enrofloxacin that is estimated to be consumed a day, based on the National Nutrition Survey, when it is assumed that the substance remains in each food up to the draft maximum residue limit. The details of the estimation are shown in the table given in the last page of this document.
TMDI/ADI (%)
National average 10.41
Young children, aged between 1 and 6 41.40
Pregnant women 11.83
d. MRLs for enfloxacin are already established in the revised Specifications and Standards for
Food, Food Additives, Etc (Part I Food, Section A General Compositional Standards for Food,
Item 7). These MRLs have, however, been provisionally established for the implementation of
the positive list system for agricultural chemical residues in food, which became effective on
May 29, 2006. In this activity, the MHLW has revised the provisional MRLs based on more
appropriate and scientific assessment. The provisional MRLs will be removed from Item 7,
and the revised MRLs will be placed in Item 6 of Section A.
Estimation of ratio of ADI (Based on the national average intake of each food and a body weight of 53.3 kg)
Note
1. [MRL for muscle] × [Sum of intakes of muscle and fat]
2. The highest MRL in the same species was adopted for calculation.
Food MRL (ppm)(A) Intake(g/person/day)(B) Estimated intake of enrofloxacin
(μg/person/day) (A) × (B)
Cattle
Muscle 0.05 19.71 0.986 1
Fat 0.05 19.71 0.986 1
Liver 0.1 0.12 0.012
Kidney 0.1 0.4 0.04
Other edible parts 1 0.05 0.42 0.021
Milk 0.05 142.7 7.14
Porcine
Muscle 0.05 35.83 1.7921
Fat 0.05 35.83 1.7921
Liver 0.1 0.17 0.017
Kidney 0.1 0.04 0.004
Other edible parts1 0.05 0.39 0.020
Other terrestrial mammals
Muscle 0.05 0.33 0.0332
Fat 0.05 0.33 0.0332
Liver 0.1 0.33 0.0332
Kidney 0.1 0.33 0.0332
Other edible parts1 0.05 0.33 0.0332
Chicken
Muscle 0.05 19.76 0.9881
Fat 0.05 19.76 0.9881
Liver 0.1 0.29 0.029
Kidney 0.1 0 0
Other edible parts1 0.1 0.15 0.015
Food MRL (ppm)(A) Intake(g/person/day)(B) Estimated intake of enrofloxacin
(μg/person/day) (A) × (B)
Other fowls
Muscle 0.05 0.11 0.0112
Fat 0.05 0.11 0.0112
Liver 0.1 0.11 0.0112
Kidney 0.1 0.11 0.0112
Other edible parts1 0.1 0.11 0.0112
Total (μg/person/day) 11.10
Acceptable Daily Intake (μg/person/day) 106.6
TMDI/ADI (%) 10.41
(III) Discussion on the Partial Revision of Specifications and Standards for Frozen Foods Served after Heating
(Summary)
I Background
Frozen bread dough and its variations whose main ingredient is wheat flour
are categorized as “frozen foods served (excluding products which are heated before they
are frozen)” in the specifications and standards for food and food additives based on the
Japanese Food Sanitation Law. The law requires all the foods categorized in this food
group to test negative for E.coli. Some reports reveal that wheat flour may be contaminated with E.coli. It is very difficult to keep these products free from E. coli contamination because complete bacterial killing is technically impossible in the production course without any
preheating treatment before freezing process. The Ministry of Health, Labour and
Welfare (MHLW) has determined that the application of the E. coli requirement to the
frozen wheat flour dough products is not practicable and asked the Food Safety
Committee (FSC) to conduct risk assessment.
In April 2006, the FSC made the conclusion: For frozen bread dough and its variations whose main ingredient is wheat flour and which require heating treatment before consumption, the abolishment of the requirement (negative for E. coli) is unlikely to lead to an increase in health risks as long as they are sufficiently heated or baked before consumption. In response to the conclusion, the MHLW will revise the specifications and standards for the frozen foods served after heating (excluding products which are heated before they are frozen).